Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.   Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a...

Chinese pharmaceutical market value is about USD 110 billion in 2009, and it has become the world’s second largest market. Chinese pharmaceutical firms are becoming a growing player in global pharmaceutical chains. In this paper, sample firms are selected and surveyed with a focus on effective internationalization strategies and paths, through an empirical research, this paper summarizes the in...

Malaysia is reliant on the availability of generic medicines to contain the rising national pharmaceutical expenditure. This paper assesses the factors determining the market entry of a new generic medicine following patent expiration on the innovator product in Malaysia. Data were gathered by using mail survey approach. The prevalidated Likert-scale questionnaire was mailed to all licensed mem...

In today's competitive world, there are several strategies to deal with the fast changing environment, among which New product development (NPD) is a common strategy. However, almost half of the resources that companies devote to NPD are spent on products that may fail. This issue is particularly highlighted in the pharmaceutical industry mainly because of a long development-time, low success r...

Continuous pharmaceutical manufacturing together with PAT (Process Analytical Technology) provides a suitable platform for automatic control of the end product quality as desired by QbD (quality by design)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires corrective actions in the process/raw material variability before product quality can ...

In this paper, a real time application for recognition of pharmaceutical product boxes is presented. The system developed is able to recognize in less than a second a box from a set of 10000 pharmaceutical products using as cues the box size, an optimal description of a pose invariant representation of the shape and its color. To deal with the huge amount of product database as well as to achie...

In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing its need and scope in pharmaceutical research. The c...

We model the capacity investment problem faced by pharmaceutical firms and other firms with long and risky product development cycles. These firms must balance two conflicting objectives: on one hand, the delay in scaling-up production once the product is approved must be minimized, and on the other hand, the risk of investing in ultimately unused capacity must be minimized. We develop a styliz...

Due diligence is a vital activity in the acquisition or the in-licensing of pharmaceutical compounds for market commercialization. Pharmaceutical product due diligence is a detailed investigation of the chemistry, manufacturing, and controls (CMC) information associated with a drug product. The investigation provides assurance that a given compound will meet the requisite technical and quality ...

BACKGROUND Oxacillin continues to be an important agent in the treatment of staphylococcal infections; many generic products are available and the only requirement for their approval is demonstration of pharmaceutical equivalence. We tested the assumption that pharmaceutical equivalence predicts therapeutic equivalence by comparing 11 generics with the innovator product in terms of concentratio...